Regulatory and Legal
Jul 13, 2015
Marie Thibault Public Citizen, a public advocacy group, wants to see a Sanofi surgical device taken off the market almost 20 years after it received FDA...
Jul 06, 2015
Marie Thibault The Essure permanent birth control device is set to receive more scrutiny. FDA recently announced that it will convene a September 24 meeting...
Jul 02, 2015
Marie Thibault Legislators have considered several pieces of legislation related to medical innovation this session, including the "21st Century Cures...
Jun 29, 2015
Marie Thibault   If you thought the definition of a "surgical gown" was obvious, think again. FDA has set out its policy on what is and is not a...
Jun 25, 2015
Marie Thibault As part of its unique device identifier rule, FDA has published draft guidance, "Unique Device Identification: Direct Marking of Devices,...
Jun 24, 2015
Marie Thibault FDA has published draft guidance to give industry a better idea of what the agency looks at when deciding whether to approve an Investigational...
Jun 12, 2015
Marie Thibault One of the patent reform bills introduced in this Congressional session—the Innovation Act (H.R. 9) is set to advance to the House floor...
Jun 11, 2015
Marie Thibault   Various stakeholders have banded together to encourage legislators to push for the addition of implantable medical device unique device...
Jun 09, 2015
Marie Thibault The clock is ticking on one of FDA's key initiatives to get groundbreaking medical devices to needy patients quickly. Involving both FDA and...
Jun 02, 2015
Marie Thibault Last week, the China Food and Drug Administration (CFDA) announced a major step up in registration fees for drugs and devices. According to a...